- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00344812
Opioid Maintenance Medications Comparison Study
June 26, 2006 updated by: Johns Hopkins University
A 17 week, double-blind, randomized, parallel group, four arm design outpatient study comparing LAAM, buprenorphine and two dose levels of methadone for the treatment of opioid dependence.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
220
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21224
- Behavioral Pharmacology Research Unit; Johns Hopkins Bayview Campus
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion
- age 21 to 55 years
- diagnosis of opioid dependence by criteria of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
- evidence of recent opioid use on toxicologic screening
Exclusion
- serious medical or psychiatric illness requiring long-term medication
- positive pregnancy test
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Drug use
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Study retention
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Secondary Outcome Measures
Outcome Measure |
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Safety
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rolley E Johnson, PharmD, Johns Hopkins University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1996
Study Completion
June 1, 1998
Study Registration Dates
First Submitted
June 26, 2006
First Submitted That Met QC Criteria
June 26, 2006
First Posted (Estimate)
June 27, 2006
Study Record Updates
Last Update Posted (Estimate)
June 27, 2006
Last Update Submitted That Met QC Criteria
June 26, 2006
Last Verified
March 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Narcotic-Related Disorders
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Narcotic Antagonists
- Respiratory System Agents
- Antitussive Agents
- Buprenorphine
- Methadone
Other Study ID Numbers
- BPR-95-07-24-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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